BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA19-9

    MDR report key: 2592755 · Received May 30, 2012

    Report

    Report Number
    1415939-2012-00220
    Event Type
    Malfunction
    Date Received
    May 30, 2012
    Date of Event
    May 17, 2012
    Report Date
    May 24, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Removal / Correction Number
    1415939-05/30/12-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: JIT, JJX (B)(4) EVALUATION OF THE ISSUE REVEALED THAT THE CONJUGATE COMPONENT OF THE ARCHITECT CA19-9 AFFECTED REAGENT LOTS CONTRIBUTED TO ELEVATED CA19-9 PATIENT SAMPLE CONCENTRATIONS. ALL AFFECTED LOTS SHARE THE SAME CONJUGATE COMPONENT. ABBOTT ISSUED A PRODUCT RECALL FOR THE SIX AFFECTED LOTS (08851M500, 08849M500, 10122M500, 08852M500, 08853M500, 10040M500) OF THE ARCHITECT CA19-9 REAGENT, INSTRUCTING CUSTOMERS TO DISCONTINUE USE AND DESTROY ANY REMAINING INVENTORY OF THE AFFECTED LOTS. AN INITIAL MDR NOTIFICATION WAS SUBMITTED FOR EACH AFFECTED LOT IN THIS REMEDIAL ACTION. REFERENCE MDR NUMBERS: 1415939-2012-00221 FOR LOT 08849M500; 1415939-2012-00222 FOR LOT 10122M500; 1415939-2012-00223 FOR LOT 08852M500-2K91-25; 1415939-2012-00224 FOR LOT 08853M500-2K91-25; 1415939-2012-00225 FOR LOT 10040M500-2K91-25 FOR THE ADDITIONAL MDRS SUBMITTED.

    Description of Event or Problem · 1

    ABBOTT HAS RECEIVED COMPLAINTS REGARDING A SHIFT UP IN PATIENT RESULTS WHEN USING CERTAIN LOTS OF ARCHITECT CA 19-9XR REAGENT. A PRODUCT DEFICIENCY WAS IDENTIFIED DUE TO A SHIFT UP IN PATIENT RESULTS WHEN USING ARCHITECT CA 19-9XR ASSAY, LIST NUMBER 2K91-20 LOT 08851M500, LIST NUMBER 2K91-25 LOTS 08852M500, 08853M500, AND 10040M500, AND LIST NUMBER 2K91-27, LOTS 08849M500 AND 10122M500. AS OF (B)(6) 2012, FIVE COMPLAINTS FOR UNNECESSARY TREATMENTS / DIAGNOSTIC TESTS HAVE BEEN RECEIVED; HOWEVER, THERE WERE NO KNOWN ADVERSE CONSEQUENCES. THE ARCHITECT CA 19-9XR ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF (B)(4) REACTIVE DETERMINANTS IN HUMAN SERUM OR PLASMA ON THE ARCHITECT I SYSTEM. THE ARCHITECT CA-19-9XR ASSAY IS TO BE USED AS AN AID IN THE MANAGEMENT OF PANCREATIC CANCER PATIENTS IN CONJUNCTION WITH OTHER CLINICAL METHODS. THE POTENTIAL TO GENERATE FALSELY INCREASED CA19-9 RESULTS MAY LEAD THE PHYSICIAN TO ERRONEOUSLY SUSPECT TUMOR RECURRENCE IN THE MANAGEMENT OF PANCREATIC CANCER PATIENTS. THIS COULD RESULT IN UNNECESSARY ADDITIONAL DIAGNOSTIC TESTING. A PRODUCT RECALL HAS BEEN ISSUED AND REPORTED UNDER (B)(4) FOR THE ARCHITECT CA19-9 REAGENT LOTS TO THE FDA 21CFR806 ON (B)(4), 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA19-9 NIG ABBOTT LABORATORIES 08851M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT ANALYZER